Voyager Therapeutics, Inc. (NASDAQ: VYGR), uniQure N.V. (NASDAQ: QURE), Axsome Therapeutics, Inc. (NASDAQ: AXSM), Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) and CRISPR Therapeutics AG (NASDAQCRSP) are among the biggest biotech movers in Monday's session.
Voyager Gains On Lifting of Clinical Hold On Huntington's Disease Gene Therapy: Voyager, a gene therapy company developing treatments for severe neurological diseases, said the Food and Drug Administration has removed the clinical hold imposed on the company's investigational new drug application for VY-HTT01.
VY-HTT01 is a gene therapy candidate that is being evaluated for the treatment of Huntington's disease.
The FDA has communicated to the company that it can proceed with the planned Phase 1/2 study. The company said it plans to initiate the study this year.
Voyager was jumping 20.13% to $5.61.
uniQure Says Clinical Hold On Phase 3 Hemophilia Gene Therapy Study Removed: uniQure, a gene therapy company, said the FDA removed the clinical hold imposed on its late-stage hemophilia B gene therapy study. This follows the regulatory agency deeming that the company has satisfactorily addressed all issues identified by it regarding the single patient diagnosed with liver cancer in the HOPE-B pivotal trial.
The clinical hold on the gene therapy, named etranacogene dezaparvovec, was announced in December.
uniQure shares were advancing 10.50% to $35.61.
Axsome Gains After FDA Accepts For Priority Review Regulatory Application For Depression Drug: Axsome, which is developing treatments for central nervous system disorders, said the FDA has accepted for filing its NDA for AXS-05 for the treatment of major depressive disorder. The application has also been granted priority review.
AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.
Axsome shares were adding 9.82% to $58.08.
Reviva's Schizophrenia Drug Aces Mid-stage Study Reviva, a clinical-stage biopharma developing therapies for central nervous system, cardiovascular, metabolic and inflammatory diseases, announced positive Phase 2 data for its lead drug candidate RP5063 in acute schizophrenia.
The investigational asset met its primary endpoint, which was reduction in total Positive and Negative Syndrome Scale at the end of the treatment from baseline versus placebo, and all safety endpoints, including clinical, labs, body weight, prolactin, lipids, fasting glucose, and EKG, the company said.
Reviva was soaring 82% to $7.87.
Crispr's Gene Editing Therapy for Bleeding Disorder Gets Priority Medicines Designation In Europe: Crispr and partner Vertex Pharmaceuticals Incorporated (VRTX) said the European Medicines Agency has granted Priority Medicines designation to CTX001, an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy for the treatment of transfusion-dependent beta thalassemia.
Priority Medicines designation is a regulatory mechanism that provides early and proactive support to developers of promising medicines to optimize development plans and speed up evaluations so these medicines can reach patients faster.
Crispr shares were moving up 7% to $135.40
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